FDA 510(k) Application Details - K060204

Device Classification Name	Epstein-Barr Virus, Other   More FDA Info for this Device
510(K) Number	K060204
Device Name	Epstein-Barr Virus, Other
Applicant	DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US Other 510(k) Applications for this Company
Contact	DAVID M IKEDA Other 510(k) Applications for this Contact
Regulation Number	866.3235   More FDA Info for this Regulation Number
Classification Product Code	LSE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/26/2006
Decision Date	10/18/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review